Healthy VolunteersNCT03665610
Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites
An observational study of Healthy Volunteers, run by Celgene at 2 sites in United States.
Trial summary
Study Design This is a Phase 1, multi-center, extension study to collect safety data up to 75 ± 10 days postdose from the Phase 1 studies RPC01-1912, RPC01-1913 and RPC01-1914 (ie, the "parent studies") and PK/PD data up to 75 ± 10 days postdose from studies RPC01-1913 and RPC01-1914. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ozanimod
- How many people
- 212 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2018to 10 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The approximate number of subjects will be 230 for safety data (from parent studies RPC01-1912, RPC01-1913, and RPC01-1914) and 129 for PK/PD data (from parent studies RPC01-1913 and RPC01-1914).
Who may be able to join
- For the mandatory data collection for safety, subjects who enrolled in the Phase 1 studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or investigational product (IP) as applicable per the parent studies are eligible, except for subjects who discontinued during Period 1 of study RPC01-1913.
- For the optional sparse sampling for PK/PD, subjects must satisfy the following criteria:
- Subjects in study RPC01-1913 have completed the study at least through Period 2 and completed the 7 ± 2 days postdose follow-up assessments; or subjects in study RPC01-1914 have completed the study through the 7 ± 2 days postdose follow-up.
- Subjects had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments.
- Subjects must be able to comprehend and provide written informed consent, and must be able to comply with the requirements of the study, including the study visit schedule and other protocol requirements or restrictions.
Who cannot join
- No Exclusion Criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PPD Phase 1 Clinic
Austin, Texas, 78744
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Multi-center, Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites in Healthy Adult Subjects
Study Design
This is a Phase 1, multi-center, extension study to collect safety data up to 75 ± 10 days postdose from the Phase 1 studies RPC01-1912, RPC01-1913 and RPC01-1914 (ie, the "parent studies") and PK/PD data up to 75 ± 10 days postdose from studies RPC01-1913 and RPC01-1914. This study consists of two parts:
Read more
- Mandatory data collection for safety: Subjects enrolled in the parent studies were consented to have data on adverse events (AEs), serious adverse events (SAEs), pregnancy test results, and concomitant medications up to the 75 ± 10 days postdose follow-up collected and reported in this study.
- Optional sparse sampling for PK/PD: Eligible subjects from studies RPC01-1913 and RPC01-1914 will be offered the opportunity to return to the clinical research unit (CRU) at four separate occasions for PK/PD sample collections up to the 75 ± 10 days postdose follow-up. After signing the informed consent form, eligible subjects will be randomized to one of three sequences with stratification by site/protocol. Subjects will return to the CRU in the morning (between approximately 8 am and 11 am) once at each of the four time windows.
Study Population The approximate number of subjects will be 230 for safety data and 129 for PK/PD data.
Length of Study The study duration is up to 84 days.
- Conditions
- Healthy Volunteers
- Being tested
- ozanimod
- Keywords
- Pharmacodynamics, Pharmacokinetics, Ozanimod, Safety, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozanimodDrug
ozanimod
| Study group | Role | What they receive |
|---|---|---|
| Mandatory Safety Population | All subjects who enrolled in studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or IP (per parent studies), excluding subjects who discontinued during Period 1 of study RPC01-1913. Receives: Drug: ozanimod | |
| Optional pharmacokinetic(s) and pharmacodynamics(s) population | Subjects in study RPC01-1913 have completed the study at least through Period 2 and completed the 7 ± 2 days postdose follow-up assessments; or subjects in study RPC01-1914 have completed the study through the 7 ± 2 days postdose follow-up and had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
The incidence, severity, and relationship of TEAEs.
Measured: From enrollment up to 75 +/- 10 days after the last dose in the parent study (RPC01-1912, RPC01-1913, or RPC01-1914)
Secondary outcomes (2)
Pharmacodynamics - absolute lymphocyte count (ALC)
The absolute lymphocyte count (ALC) will be determined via hematology test
Measured: Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)
Pharmacodynamics - lymphocyte subsets
Lymphocyte subsets will be measured using the immune cell monitoring epigenetic platform
Measured: Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start10 Sep 2018
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Tran, Pharm.D, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665610
- Sponsor's protocol ID
- RPC01-1915
- Other IDs
- U1111-1219-5905
- Status last verified
- Feb 2019
- First submitted
- 7 Sep 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03665610
- Acronym / sponsor ID
- RPC01-1915
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacodynamics, Pharmacokinetics, Ozanimod, Safety, Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design
This is a Phase 1, multi-center, extension study to collect safety data up to 75 ± 10 days postdose from the Phase 1 studies RPC01-1912, RPC01-1913 and RPC01-1914 (ie, the "parent studies") and PK/PD data up to 75 ± 10 days postdose from studies RPC01-1913 and RPC01-1914. This study consists of two parts:
- Mandatory data collection for safety: Subjects enrolled in the parent studies were consented to have data on adverse events (AEs), serious adverse events (SAEs), pregnancy test results, and concomitant medications up to the 75 ± 10 days postdose follow-up collected and reported in this study.
- Optional sparse sampling for PK/PD: Eligible subjects from studies RPC01-1913 and RPC01-1914 will be offered the opportunity to return to the clinical research unit (CRU) at four separate occasions for PK/PD sample collections up to the 75 ± 10 days postdose follow-up. After signing the informed consent form, eligible subjects will be randomized to one of three sequences with stratification by site/protocol. Subjects will return to the CRU in the morning (between approximately 8 am and 11 am) once at each of the four time windows.
Study Population The approximate number of subjects will be 230 for safety data and 129 for PK/PD data.
Length of Study The study duration is up to 84 days.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandatory Safety Population | – | Drug: ozanimodAll subjects who enrolled in studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or IP (per parent studies), excluding subjects who discontinued during Period 1 of study RPC01-1913. |
| Optional pharmacokinetic(s) and pharmacodynamics(s) population | – | –Subjects in study RPC01-1913 have completed the study at least through Period 2 and completed the 7 ± 2 days postdose follow-up assessments; or subjects in study RPC01-1914 have completed the study through the 7 ± 2 days postdose follow-up and had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The approximate number of subjects will be 230 for safety data (from parent studies RPC01-1912, RPC01-1913, and RPC01-1914) and 129 for PK/PD data (from parent studies RPC01-1913 and RPC01-1914).
Key inclusion criteria (5 listed)
- For the mandatory data collection for safety, subjects who enrolled in the Phase 1 studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or investigational product (IP) as applicable per the parent studies are eligible, except for subjects who discontinued during Period 1 of study RPC01-1913.
- For the optional sparse sampling for PK/PD, subjects must satisfy the following criteria:
Key exclusion criteria (1 listed)
- No Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozanimodozanimod | Drug | Mandatory Safety Population |
Primary outcome
Adverse events (AEs)
Time frame: From enrollment up to 75 +/- 10 days after the last dose in the parent study (RPC01-1912, RPC01-1913, or RPC01-1914)
The incidence, severity, and relationship of TEAEs.
2 secondary outcomes
Pharmacodynamics - absolute lymphocyte count (ALC)
Time frame: Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)
Pharmacodynamics - lymphocyte subsets
Time frame: Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Tran, Pharm.D study director
Celgene
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Celgene at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: From enrollment up to 75 +/- 10 days after the last dose in the parent study (RPC01-1912, RPC01-1913, or RPC01-1914)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.